In Bruesewitz v. Wyeth LLC, 131 S. Ct. 1068 (Feb. 22, 2011), a child’s pediatrician administered doses of the diphtheria-tetanus-pertussis (“DTP”) vaccine according to the Center for Disease Control’s recommended childhood immunization schedule. Within 24 hours of her vaccination, the child began to experience seizures, suffering over 100 of them within a single month. Her doctors eventually diagnosed her with “residual seizure disorder” and “developmental delay.” Thereafter, the child’s parents commenced a proceeding seeking compensation for her injuries pursuant to procedures set forth in the National Childhood Vaccine Injury Act of 1986 (“NCVIA”).
Under the NCVIA, a person injured by a vaccine may file a petition for compensation from the manufacturer in the United States Court of Federal Claims, naming the Secretary of Health and Human Services as the respondent. Within 240 days, a special master is required to make an informal adjudication of the petition applying a detailed no-fault compensation scheme set forth in the statute. Any objections are subject to review under similar time constraints by the claims court, which then enters final judgment. A claimant may choose either to accept the court’s judgment and forego a tort action against the manufacturer or reject the judgment and pursue such an action.
After the special master denied plaintiffs’ claim and the claims court confirmed the denial, plaintiffs filed suit in Pennsylvania state court alleging the defective design of the DTP vaccine caused their child’s disabilities and the manufacturer was subject to both strict and negligence liability for defective design under Pennsylvania common law. Upon removal of the action to federal court, the United States District Court for the Eastern District of Pennsylvania granted summary judgment for defendant, holding that Pennsylvania law was expressly preempted by an NCVIA provision that “[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side-effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” Plaintiffs appealed and the United States Court of Appeals for the Third Circuit affirmed. The United State Supreme Court granted certiorari to address the scope of the NCVIA’s preemption provision.
The Court held that the NCVIA preempts all design defect claims seeking compensation for injury or death caused by a vaccine’s side-effects. The Court reasoned that the language of the provision referring to side-effects that were “unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings” took the vaccine’s particular design as a given and thus extinguished liability for injuries arising out of that design. In addition, the three traditional bases for product liability are defects in design, manufacture and warnings, and the provision’s mention only of the latter two suggested that claims arising from the first were what Congress intended to preempt. By contrast, plaintiffs’ argument that the NCVIA preempts only claims arising from side-effects that were unavoidable by the adoption of feasible alternative designs was not supported by the statutory language. Further, plaintiffs’ contention that design defect claims were immunized only if the manufacturer had properly manufactured the vaccine and warned about its risks was not grammatically supported, as the statute used the phrase “even though” rather than “and” after the word “unavoidable.”
Beyond the language of the preemption clause itself, the Court noted that other provisions of the statute, and of the United States Food and Drug Administration regulations thereunder, impose various requirements on both vaccine manufacture and vaccine warnings, while there are no provisions about vaccine design. Thus both the statutory structure and language supported the result reached by the Court. In light of this, the Court stated there was no need to resort to consideration of legislative history, but in any event examination of that history provided no support for plaintiffs’ arguments. Indeed, part of a House committee report counseled claimants who could not prove a manufacturing or warning defect to pursue the compensation scheme rather than a tort remedy, again supporting the conclusion that there was no tort remedy for design defects.